Scientific Opinion on a request from the European Commission for the assessment of the scientific elements put forward by Hungary to support the prohibition for the placing on the market of GM potato EH92-527-1 for cultivation purposes in Hungary

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Article
Panel on Genetically Modified Organisms
Acknowledgements

The Panel wishes to thank the members of the Standing Working Group on Molecular Characterisation on GMO Applications and, among these, Sirpa Kärenlampi, for the preparatory work on this scientific opinion, and EFSA staff member Ana Gomes, for the support provided to the development of this EFSA scientific output.

EFSA Journal
EFSA Journal 2012;10(12):3021 [10 pp.].
doi
10.2903/j.efsa.2012.3021
Panel members at the time of adoption
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00615
Adopted
5 December 2012
Published
19 December 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Hungary notified to the European Commission its scientific arguments justifying the implementation of a national safeguard measure prohibiting the placing on the market of GM potato EH92-527-1 for cultivation purposes in Hungary, after which the European Commission asked the European Food Safety Authority (EFSA) to assess the scientific information supporting the prohibition. Having considered the information package provided by Hungary and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that (i) no new data specific to the safety of the nptII gene have been provided; (ii) the therapeutic relevance of kanamycin and neomycin was already addressed in the previous EFSA opinion on antibiotic resistance marker genes and kanamycin resistance in Mycobacterium tuberculosis results largely from chromosomal mutations and not from the transfer of aminoglycoside resistance genes such as nptII; (iii) the knowledge gaps and uncertainties highlighted in the Hungarian document have already been considered in the previous EFSA opinion on antibiotic resistance marker genes, and no new information on the safety of nptII gene as present in the GM potato EH92-527-1 has been identified in the scientific literature that would cause the GMO Panel to change its previous conclusions. Therefore, the EFSA GMO Panel concludes that no grounds exist to date that would lead to reconsideration of its opinion on GM potato EH92-527-1.

Keywords
GMOs, potato Solanum tuberosum, EH92-527-1, Amflora, Hungary, safeguard clause, human and animal health, environment, Directive 2001/18/EC.
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Number of Pages
10